MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number RI-2

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 involved in the incident was received for evaluation on june 3, 2021; evaluation of the unit is in process.The user facility reported that the ri-2 alarmed during a procedure but was unable to provide a description of the specific alarm exhibited.When the rapid infuser detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.The operator's manual also provides possible conditions and additional recommended operator actions.Without details of the specific alarm experienced or results of the investigation, it is difficult to determine what occurred in this case.The manufacturing records for this ri-2 serial number were reviewed and no anomalies were identified.No patient injury was reported.A follow-up report will be submitted upon completion of the investigation.

Event Description

The user facility reported that the rapid infuser, ri-2 alarmed during a procedure.The user was unable to provide the specific alarm code exhibited.

Manufacturer Narrative

The user facility reported that the ri-2 alarmed during a procedure but was unable to provide a description of the specific alarm exhibited.When the unit was returned to belmont for investigation, no alarm was identified; the unit performed according to specifications upon receipt.When the rapid infuser detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.The operator's manual also provides possible conditions and additional recommended operator actions.Without details of the specific alarm experienced or the ability to reproduce it, a root cause cannot be established.The manufacturing records for this ri-2 serial number were reviewed and no anomalies were identified.No patient injury was reported.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 12021912
• MDR Text Key: 267828558
• Report Number: 1219702-2021-00084
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1